CYIL vol. 10 (2019)

MARTIN ŠOLC CYIL 10 ȍ2019Ȏ Several risks of germline editing are highlighted including mosaicism where some cells in the body are not edited (as is the case in one of the Chinese twins) or unintended harmful effects for the edited individual or her descendants. An evaluation of the risks and benefits of germline editing is difficult. However, the Organizing Committee believes that “germline genome editing could become acceptable in the future if these risks are addressed and if a number of additional criteria are met. These criteria include strict independent oversight, a compelling medical need, an absence of reasonable alternatives, a plan for long-term follow-up, and attention to societal effects.“ While the risks are still too great to permit the germline editing, the fast development of the field suggests that the situation can change in the future. For this reason, the Statement calls for defining “a rigorous, responsible translational pathway” towards germline editing clinical trials. Adherence to widely accepted standards for clinical research will be required as a part of the translational pathway. These standards must include special guidance documents focused on genome editing: the Statement demonstratively refers to the National Academies of Sciences, Engineering, and Medicine’s document Human Genome Editing: Science, Ethics, and Governance of 2017 65 (see below) and the Nuffield Council on Bioethics 66 document Genome Editing and Human Reproduction: Social and Ethical Issues of 2018. 67, 68 Furthermore, several new standards reflecting special aspects of germline editing will have to be established 69 . The Statement explicitly mentioned Jiankui’s claim of the birth of genetically edited twins, calling it “unexpected and deeply disturbing” . An independent investigation was suggested to verify the claim. If true, the experiment was condemned as irresponsible and failing to conform to international norms 70 . The Organizing Committee repeated the call for an ongoing international forum fostering broad public dialogue and working on a number of issues related to genome editing. Academic bodies around the world were also invited to “continue the practice of holding international summits” . The Summits have been sometimes criticised for taking a too weak stand against the germline editing 71 . Even though both Statements clearly reject germline editing unless and 65 See The National Academies of Sciences, Engineering, and Medicine. Human Genome Editing: Science, Ethics, and Governance. The National Academies Press, Washington, DC 2017. Also available at accessed 30 May 2019. 66 The Nuffield Council on Bioethics is a London-based independent bioethical body established in 1991. See accessed 30 May 2019. 67 See The Nuffield Council on Bioethics. Genome Editing and Human Reproduction: Social and Ethical Issues. The Nuffield Council on Bioethics, London 2018. Also available at accessed 30 May 2019. 68 We would like to refer the reader who would be interested in further reading also to another Nuffield Council on Bioethics document: The Nuffield Council on Bioethics. Genome Editing: an Ethical Review . The Nuffield Council on Bioethics, London 2016. Also available at < http://nuffieldbioethics.org/wp-content/uploads/ Genome-editing-an-ethical-review.pdf> accessed 30 May 2019. 69 The Statement speaks of “standards for preclinical evidence and accuracy of gene modification, assessment of competency for practitioners of clinical trials, enforceable standards of professional behavior, and strong partnerships with patients and patient advocacy groups.” 70 According to the Statement, the flaws of the experiment “include an inadequate medical indication, a poorly designed study protocol, a failure to meet ethical standards for protecting the welfare of research subjects, and a lack of transparency in the development, review, and conduct of the clinical procedures” . 71 See for example KNOEPFLER, Paul. Why CRISPR baby production (if it happened) was unethical &

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